A Study to Determine the Effectiveness and Tolerability of MK8141 in Patients With High Blood Pressure - Full Text View

Sponsor:	Merck
Collaborator:	Actelion
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00543413

Purpose

This study will evaluate the effectiveness and tolerability of MK8141 in lowering blood pressure in patients who have hypertension (high blood pressure).

Condition	Intervention	Phase
Hypertension	Drug: MK8141 Drug: Comparator: placebo (unspecified) Drug: Enalapril	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Study to Assess the Efficacy and Tolerability of MK8141 in Hypertensive Patients

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Enalapril Enalapril maleate Enalaprilat

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

To measure the tolerability and effectiveness of MK8141 in lowering 24-hour mean ambulatory blood pressure versus placebo after 4 weeks of treatment. [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Compare MK8141 versus placebo in lowering 24-hour mean sitting blood pressure by ambulatory blood pressure monitoring and in lowering trough mean sitting diastolic and systolic blood pressure after 4 weeks of treatment. [ Time Frame: after 4 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment:	160
Study Start Date:	October 2007
Study Completion Date:	July 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Arm 1: Drug 250 mg	Drug: MK8141 MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period
Experimental: 2 Arm 2: Drug 500 mg	Drug: MK8141 MK8141 250 mg tablet once daily; 500 mg tablet once daily 4 week treatment period
Active Comparator: 3 Arm 3: Active Comparator	Drug: Enalapril Enalapril 20 mg tablet once daily. 4 week treatment period. Other Name: Vasotec®
Placebo Comparator: 4 Arm 4: Pbo Comparator	Drug: Comparator: placebo (unspecified) MK8141 Pbo tablet once daily. 4 week treatment period.

Eligibility

Ages Eligible for Study:	35 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

You are 35 to 65 years of age
In the past 14 days you have not been treated for hypertension
In the past 14 days you have not taken more than 2 medications to treat high blood pressure
You are a woman who is not able to have children or do not use birth control

Exclusion Criteria:

You are taking more than 2 medications to treat high blood pressure
You have a history of a stroke, transient ischemic attack (TIA), heart attack, congestive heart failure, coronary artery bypass surgery
You have Type 1 or 2 diabetes mellitus
You have an active liver disease, gallbladder disease, or bowel disease
You are HIV positive
You have certain types of cancer
You abuse drug or alcohol
You have participated in another clinical study in last 4 weeks

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543413

Sponsors and Collaborators

Merck

Actelion

Investigators

Study Director:

Medical Monitor

Merck

More Information

No publications provided

Responsible Party:	Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier:	NCT00543413 History of Changes
Other Study ID Numbers:	2007_587, MK8141-006
Study First Received:	October 5, 2007
Last Updated:	November 20, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hypertension
Vascular Diseases
Cardiovascular Diseases
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors

Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012